Joely Keen, A.P.R.N.; Decision and Order, 13882-13884 [2025-05164]
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13882
Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
practice medicine in Texas, the state in
which he is registered with DEA.3
lotter on DSK11XQN23PROD with NOTICES1
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (CSA) ‘‘upon a finding
that the registrant . . . has had his State
license or registration suspended . . .
[or] revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
With respect to a practitioner, DEA has
also long held that the possession of
authority to dispense controlled
substances under the laws of the state in
which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a practitioner’s registration. Gonzales v.
Oregon, 546 U.S. 243, 270 (2006) (‘‘The
Attorney General can register a
physician to dispense controlled
substances ‘if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’ . . . The very
definition of a ‘practitioner’ eligible to
prescribe includes physicians ‘licensed,
registered, or otherwise permitted, by
the United States or the jurisdiction in
which he practices’ to dispense
controlled substances. § 802(21).’’). The
Agency has applied these principles
consistently. See, e.g., James L. Hooper,
M.D., 76 FR 71371, 71372 (2011), pet.
for rev. denied, 481 F. App’x 826 (4th
Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).4
3 Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency
decision rests on official notice of a material fact
not appearing in the evidence in the record, a party
is entitled, on timely request, to an opportunity to
show the contrary.’’ The material fact here is that
Registrant, as of the date of this decision, is not
licensed to practice medicine in Texas.
Accordingly, Respondent may dispute the Agency’s
finding by filing a properly supported motion for
reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such
motion and response shall be filed and served by
email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
4 This rule derives from the text of two provisions
of the CSA. First, Congress defined the term
‘‘practitioner’’ to mean ‘‘a physician . . . or other
person licensed, registered, or otherwise permitted,
by . . . the jurisdiction in which he practices . . . ,
to distribute, dispense, . . . [or] administer . . . a
controlled substance in the course of professional
practice.’’ 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner’s
registration, Congress directed that ‘‘[t]he Attorney
General shall register practitioners . . . if the
applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he
practices.’’ 21 U.S.C. 823(g)(1). Because Congress
has clearly mandated that a practitioner possess
state authority in order to be deemed a practitioner
under the CSA, DEA has held repeatedly that
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17:43 Mar 26, 2025
Jkt 265001
According to Texas statute,
‘‘dispense’’ means ‘‘the delivery of a
controlled substance in the course of
professional practice or research, by a
practitioner or person acting under the
lawful order of a practitioner, to an
ultimate user or research subject. The
term includes the prescribing,
administering, packaging, labeling, or
compounding necessary to prepare the
substance for delivery.’’ Tex. Health &
Safety Code Ann. section 481.002(12)
(2024). Further, a ‘‘practitioner’’
includes ‘‘a physician . . . or other
person licensed, registered, or otherwise
permitted to distribute, dispense,
analyze, conduct research with respect
to, or administer a controlled substance
in the course of professional practice or
research in this state.’’ Id.
section 481.002(39)(A).
Here, the undisputed evidence in the
record is that Respondent lacks
authority to practice medicine in Texas.
As discussed above, an individual must
be a licensed practitioner to dispense a
controlled substance in Texas. Thus,
because Respondent lacks authority to
practice medicine in Texas and,
therefore, is not authorized to handle
controlled substances in Texas,
Respondent is not eligible to maintain a
DEA registration. RD, at 6. Accordingly,
the Agency will order that Respondent’s
DEA registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BD9134254 issued to
Willard J. Davis, D.O. Further, pursuant
to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications
of Willard J. Davis, D.O., to renew or
modify this registration, as well as any
other pending application of Willard J.
Davis, D.O., for additional registration
in Texas. This Order is effective April
28, 2025.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on March 20, 2025, by Acting
Administrator Derek Maltz. That
document with the original signature
and date is maintained by DEA. For
administrative purposes only, and in
revocation of a practitioner’s registration is the
appropriate sanction whenever he is no longer
authorized to dispense controlled substances under
the laws of the state in which he practices. See, e.g.,
James L. Hooper, M.D., 76 FR 71371–72; Sheran
Arden Yeates, M.D., 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104, 51105
(1993); Bobby Watts, M.D., 53 FR 11919, 11920
(1988); Frederick Marsh Blanton, M.D., 43 FR
27617.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
compliance with requirements of the
Office of the Federal Register, the
undersigned DEA Federal Register
Liaison Officer has been authorized to
sign and submit the document in
electronic format for publication, as an
official document of DEA. This
administrative process in no way alters
the legal effect of this document upon
publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2025–05166 Filed 3–26–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 25–9]
Joely Keen, A.P.R.N.; Decision and
Order
On September 24, 2024, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Joely Keen, A.P.R.N., of
The Woodlands, Texas (Respondent).
OSC, at 1, 4. The OSC proposed the
revocation of Respondent’s DEA
Certificate of Registration No.
MK4402210, alleging that Respondent’s
DEA registration should be revoked
because Respondent is ‘‘without
authority to prescribe, administer,
dispense, or otherwise handle
controlled substances in the State of
Texas, the state in which [she is]
registered with DEA.’’ Id. at 2 (citing 21
U.S.C. 824(a)(3)).
On October 22, 2024, Respondent
requested a hearing,1 and on October 23,
2024, Respondent filed an Answer to
the allegations in the OSC. See Order
For Respondent To File Answer. On
November 1, 2024, the Government filed
a Motion for Summary Disposition, to
which Respondent did not respond. On
November 19, 2024, Administrative Law
Judge Paul E. Soeffing (the ALJ) granted
the Government’s Motion for Summary
Disposition and recommended the
revocation of Respondent’s registration,
finding that because Respondent lacks
state authority to handle controlled
substances in Texas, the state in which
1 Respondent initially responded to the OSC via
email on October 18, 2024, but her email did not
include a hearing request. See Respondent’s
Request for Hearing (October 18, 2024). On October
21, 2024, the Administrative Law Judge (ALJ)
directed Respondent to file a request for a hearing
if she desired one, along with an answer to the
allegations in the OSC. Order for Respondent to File
Request for Hearing and Answer and for
Government to File Evidence of Lack of State
Authority.
E:\FR\FM\27MRN1.SGM
27MRN1
Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
she is registered with DEA, ‘‘there is no
other fact of consequence for th[e]
tribunal to decide.’’ Order Granting the
Government’s Motion for Summary
Disposition, and Recommended
Rulings, Findings of Fact, Conclusions
of Law, and Decision of the
Administrative Law Judge (RD), at 5–6.
Respondent did not file exceptions to
the RD.
Having reviewed the entire record, the
Agency adopts and hereby incorporates
by reference the entirety of the ALJ’s
rulings, findings of fact, conclusions of
law, and recommended sanction as
found in the RD and summarizes and
expands upon portions thereof herein.
Findings of Fact
According to Texas online records, of
which the Agency takes official notice,
Respondent’s Texas APRN license and
Texas registered nurse license are
revoked.2 Texas Board of Nursing
License Verification Portal, https://
txbn.boardsofnursing.org/licenselookup
(last visited date of signature of this
Order). Accordingly, the Agency finds
that Respondent is not currently
licensed to practice as an APRN or
registered nurse in Texas, the state in
which she is registered with DEA.3
Additionally, as of March 27, 2024,
Respondent has not had an active
prescriptive authority agreement with a
supervisory physician, which is
required for an advanced practice
registered nurse (APRN) in Texas to
handle controlled substances. RD, at 4;
22 Tex. Admin. Code sections 193.7(a),
222.4(a)(l)(A), 222.5(a).4
Discussion
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (CSA) ‘‘upon a finding
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979).
3 Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency
decision rests on official notice of a material fact
not appearing in the evidence in the record, a party
is entitled, on timely request, to an opportunity to
show the contrary.’’ The material fact here is that
Registrant, as of the date of this decision, is not
licensed to practice medicine in Texas. Respondent
may dispute this fact by filing a properly supported
motion for reconsideration of findings of fact within
fifteen calendar days of the date of this Order. Any
such motion and response shall be filed and served
by email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
4 See also Government’s Notice of Filing of
Evidence and Motion for Summary Disposition,
Exhibit 1.
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17:43 Mar 26, 2025
Jkt 265001
that the registrant . . . has had his State
license or registration suspended . . .
[or] revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
With respect to a practitioner, DEA has
also long held that the possession of
authority to dispense controlled
substances under the laws of the state in
which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a practitioner’s registration. Gonzales v.
Oregon, 546 U.S. 243, 270 (2006) (‘‘The
Attorney General can register a
physician to dispense controlled
substances ‘if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’ . . . The very
definition of a ‘practitioner’ eligible to
prescribe includes physicians ‘licensed,
registered, or otherwise permitted, by
the United States or the jurisdiction in
which he practices’ to dispense
controlled substances. § 802(21).’’). The
Agency has applied these principles
consistently. See, e.g., James L. Hooper,
M.D., 76 FR 71371, 71372 (2011), pet.
for rev. denied, 481 F. App’x 826 (4th
Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).5
According to Texas statute,
‘‘dispense’’ means ‘‘the delivery of a
controlled substance in the course of
professional practice or research, by a
practitioner or person acting under the
lawful order of a practitioner, to an
ultimate user or research subject. The
term includes the prescribing,
administering, packaging, labeling, or
compounding necessary to prepare the
substance for delivery.’’ Tex. Health &
Safety Code Ann. section 481.002(12)
5 This rule derives from the text of two provisions
of the Controlled Substances Act (CSA). First,
Congress defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person licensed,
registered, or otherwise permitted, by . . . the
jurisdiction in which he practices . . . , to
distribute, dispense, . . . [or] administer . . . a
controlled substance in the course of professional
practice.’’ 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner’s
registration, Congress directed that ‘‘[t]he Attorney
General shall register practitioners . . . if the
applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he
practices.’’ 21 U.S.C. 823(g)(1). Because Congress
has clearly mandated that a practitioner possess
state authority in order to be deemed a practitioner
under the CSA, DEA has held repeatedly that
revocation of a practitioner’s registration is the
appropriate sanction whenever he is no longer
authorized to dispense controlled substances under
the laws of the state in which he practices. See, e.g.,
James L. Hooper, M.D., 76 FR 71371–72; Sheran
Arden Yeates, M.D., 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104, 51105
(1993); Bobby Watts, M.D., 53 FR 11919, 11920
(1988); Frederick Marsh Blanton, M.D., 43 FR
27617.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
13883
(2024). Further, a ‘‘practitioner’’
includes ‘‘an advanced practice
registered nurse or physician assistant
to whom a physician has delegated the
authority to prescribe or order a drug or
device . . . .’’ Id.
section 481.002(39)(D). Texas statute
provides that ‘‘[a] physician may
delegate to an advanced practice
registered nurse or physician assistant,
acting under adequate physician
supervision, the act of prescribing or
ordering a drug or device as authorized
through a prescriptive authority
agreement between the physician and
the advanced practice registered nurse
or physician assistant, as applicable.’’
Tex. Occ. Code Ann. section 157.0512(a)
(2024).
Here, the undisputed evidence in the
record is that Respondent lacks
authority to handle controlled
substances in Texas because her Texas
APRN license and Texas registered
nurse license have both been revoked.
Respondent also lacks authority to
handle controlled substances in Texas
because she has not had an active
prescriptive authority agreement with a
supervisory physician since March 27,
2024. As discussed above, an individual
must be a licensed practitioner to
dispense a controlled substance in
Texas, and for an advanced practice
registered nurse to meet the definition
of a practitioner, he or she must be
delegated the authority to handle
controlled substances via a prescriptive
authority agreement with a supervisory
physician.
Thus, because Respondent lacks
authority to practice as an advanced
practice registered nurse in Texas,
Respondent is not authorized to handle
controlled substances in Texas and is
therefore not eligible to maintain a DEA
registration. RD, at 5–6.
Accordingly, the Agency will order
that Respondent’s DEA registration be
revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. MK4402210 issued
to Joely Keen, A.P.R.N. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending
applications of Joely Keen, A.P.R.N., to
renew or modify this registration, as
well as any other pending application of
Joely Keen, A.P.R.N., for additional
registration in Texas. This Order is
effective April 28, 2025.
E:\FR\FM\27MRN1.SGM
27MRN1
13884
Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
Signing Authority
This document of the Drug
Enforcement Administration was signed
on March 18, 2025, by Acting
Administrator Derek Maltz. That
document with the original signature
and date is maintained by DEA. For
administrative purposes only, and in
compliance with requirements of the
Office of the Federal Register, the
undersigned DEA Federal Register
Liaison Officer has been authorized to
sign and submit the document in
electronic format for publication, as an
official document of DEA. This
administrative process in no way alters
the legal effect of this document upon
publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2025–05164 Filed 3–26–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No.1519]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Baxter
Research Lab
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 27, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instruction at that site for
lotter on DSK11XQN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
17:43 Mar 26, 2025
Jkt 265001
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefore, may
submit electronic comments on or
objections of the requested registration,
as provided in this notice. This notice
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulation. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as bulk manufacturer
of marihuana the application will be
evaluated under the criteria of 21 U.S.C.
823(a). DEA will conduct this
evaluation in the manner described in
the rule published at 85 FR 82333 on
December 18, 2020, and reflected in
DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on August 20, 2024, Baxter Research
Lab, 5200 North Lake Road, Merced,
California 95343–5001, applied to be
registered as bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Marihuana ........................
PO 00000
Frm 00033
Fmt 4703
Drug
code
Schedule
7360
I
Sfmt 4703
Controlled substance
Tetrahydrocannabinols ....
Drug
code
Schedule
I 7370 II
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05276 Filed 3–26–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1522]
Importer of Controlled Substances
Application: Patheon API Services, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon API Services, Inc. has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 28, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 28, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
SUMMARY:
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Agencies
[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Pages 13882-13884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05164]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 25-9]
Joely Keen, A.P.R.N.; Decision and Order
On September 24, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Joely Keen,
A.P.R.N., of The Woodlands, Texas (Respondent). OSC, at 1, 4. The OSC
proposed the revocation of Respondent's DEA Certificate of Registration
No. MK4402210, alleging that Respondent's DEA registration should be
revoked because Respondent is ``without authority to prescribe,
administer, dispense, or otherwise handle controlled substances in the
State of Texas, the state in which [she is] registered with DEA.'' Id.
at 2 (citing 21 U.S.C. 824(a)(3)).
On October 22, 2024, Respondent requested a hearing,\1\ and on
October 23, 2024, Respondent filed an Answer to the allegations in the
OSC. See Order For Respondent To File Answer. On November 1, 2024, the
Government filed a Motion for Summary Disposition, to which Respondent
did not respond. On November 19, 2024, Administrative Law Judge Paul E.
Soeffing (the ALJ) granted the Government's Motion for Summary
Disposition and recommended the revocation of Respondent's
registration, finding that because Respondent lacks state authority to
handle controlled substances in Texas, the state in which
[[Page 13883]]
she is registered with DEA, ``there is no other fact of consequence for
th[e] tribunal to decide.'' Order Granting the Government's Motion for
Summary Disposition, and Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the Administrative Law Judge (RD),
at 5-6. Respondent did not file exceptions to the RD.
---------------------------------------------------------------------------
\1\ Respondent initially responded to the OSC via email on
October 18, 2024, but her email did not include a hearing request.
See Respondent's Request for Hearing (October 18, 2024). On October
21, 2024, the Administrative Law Judge (ALJ) directed Respondent to
file a request for a hearing if she desired one, along with an
answer to the allegations in the OSC. Order for Respondent to File
Request for Hearing and Answer and for Government to File Evidence
of Lack of State Authority.
---------------------------------------------------------------------------
Having reviewed the entire record, the Agency adopts and hereby
incorporates by reference the entirety of the ALJ's rulings, findings
of fact, conclusions of law, and recommended sanction as found in the
RD and summarizes and expands upon portions thereof herein.
Findings of Fact
According to Texas online records, of which the Agency takes
official notice, Respondent's Texas APRN license and Texas registered
nurse license are revoked.\2\ Texas Board of Nursing License
Verification Portal, https://txbn.boardsofnursing.org/licenselookup
(last visited date of signature of this Order). Accordingly, the Agency
finds that Respondent is not currently licensed to practice as an APRN
or registered nurse in Texas, the state in which she is registered with
DEA.\3\
---------------------------------------------------------------------------
\2\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979).
\3\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision
rests on official notice of a material fact not appearing in the
evidence in the record, a party is entitled, on timely request, to
an opportunity to show the contrary.'' The material fact here is
that Registrant, as of the date of this decision, is not licensed to
practice medicine in Texas. Respondent may dispute this fact by
filing a properly supported motion for reconsideration of findings
of fact within fifteen calendar days of the date of this Order. Any
such motion and response shall be filed and served by email to the
other party and to Office of the Administrator, Drug Enforcement
Administration at [email protected].
---------------------------------------------------------------------------
Additionally, as of March 27, 2024, Respondent has not had an
active prescriptive authority agreement with a supervisory physician,
which is required for an advanced practice registered nurse (APRN) in
Texas to handle controlled substances. RD, at 4; 22 Tex. Admin. Code
sections 193.7(a), 222.4(a)(l)(A), 222.5(a).\4\
---------------------------------------------------------------------------
\4\ See also Government's Notice of Filing of Evidence and
Motion for Summary Disposition, Exhibit 1.
---------------------------------------------------------------------------
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (CSA) ``upon a finding that the registrant .
. . has had his State license or registration suspended . . . [or]
revoked . . . by competent State authority and is no longer authorized
by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, DEA has also long held
that the possession of authority to dispense controlled substances
under the laws of the state in which a practitioner engages in
professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. Gonzales v. Oregon, 546 U.S.
243, 270 (2006) (``The Attorney General can register a physician to
dispense controlled substances `if the applicant is authorized to
dispense . . . controlled substances under the laws of the State in
which he practices.' . . . The very definition of a `practitioner'
eligible to prescribe includes physicians `licensed, registered, or
otherwise permitted, by the United States or the jurisdiction in which
he practices' to dispense controlled substances. Sec. 802(21).''). The
Agency has applied these principles consistently. See, e.g., James L.
Hooper, M.D., 76 FR 71371, 71372 (2011), pet. for rev. denied, 481 F.
App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616,
27617 (1978).\5\
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\5\ This rule derives from the text of two provisions of the
Controlled Substances Act (CSA). First, Congress defined the term
``practitioner'' to mean ``a physician . . . or other person
licensed, registered, or otherwise permitted, by . . . the
jurisdiction in which he practices . . . , to distribute, dispense,
. . . [or] administer . . . a controlled substance in the course of
professional practice.'' 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner's registration, Congress
directed that ``[t]he Attorney General shall register practitioners
. . . if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he practices.'' 21
U.S.C. 823(g)(1). Because Congress has clearly mandated that a
practitioner possess state authority in order to be deemed a
practitioner under the CSA, DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction
whenever he is no longer authorized to dispense controlled
substances under the laws of the state in which he practices. See,
e.g., James L. Hooper, M.D., 76 FR 71371-72; Sheran Arden Yeates,
M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR
51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988);
Frederick Marsh Blanton, M.D., 43 FR 27617.
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According to Texas statute, ``dispense'' means ``the delivery of a
controlled substance in the course of professional practice or
research, by a practitioner or person acting under the lawful order of
a practitioner, to an ultimate user or research subject. The term
includes the prescribing, administering, packaging, labeling, or
compounding necessary to prepare the substance for delivery.'' Tex.
Health & Safety Code Ann. section 481.002(12) (2024). Further, a
``practitioner'' includes ``an advanced practice registered nurse or
physician assistant to whom a physician has delegated the authority to
prescribe or order a drug or device . . . .'' Id. section
481.002(39)(D). Texas statute provides that ``[a] physician may
delegate to an advanced practice registered nurse or physician
assistant, acting under adequate physician supervision, the act of
prescribing or ordering a drug or device as authorized through a
prescriptive authority agreement between the physician and the advanced
practice registered nurse or physician assistant, as applicable.'' Tex.
Occ. Code Ann. section 157.0512(a) (2024).
Here, the undisputed evidence in the record is that Respondent
lacks authority to handle controlled substances in Texas because her
Texas APRN license and Texas registered nurse license have both been
revoked. Respondent also lacks authority to handle controlled
substances in Texas because she has not had an active prescriptive
authority agreement with a supervisory physician since March 27, 2024.
As discussed above, an individual must be a licensed practitioner to
dispense a controlled substance in Texas, and for an advanced practice
registered nurse to meet the definition of a practitioner, he or she
must be delegated the authority to handle controlled substances via a
prescriptive authority agreement with a supervisory physician.
Thus, because Respondent lacks authority to practice as an advanced
practice registered nurse in Texas, Respondent is not authorized to
handle controlled substances in Texas and is therefore not eligible to
maintain a DEA registration. RD, at 5-6.
Accordingly, the Agency will order that Respondent's DEA
registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
MK4402210 issued to Joely Keen, A.P.R.N. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Joely Keen, A.P.R.N., to renew
or modify this registration, as well as any other pending application
of Joely Keen, A.P.R.N., for additional registration in Texas. This
Order is effective April 28, 2025.
[[Page 13884]]
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 18, 2025, by Acting Administrator Derek Maltz. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-05164 Filed 3-26-25; 8:45 am]
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